Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550232
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
IV PAPAVERINE Prior to Propess for Labor Induction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of IV PAPAVERINE 80 mg Prior to Propess on Bishop Score and Pain Double Blinded Randomized Placebo Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We aim to evaluate the effect of administering papaverine prior to PGE2 propess insertion on changes in Bishop-scores and on the induction-to-delivery interval
Detailed Description:
More than 22 of all pregnant women undergo induction of labor Induction of labor is usually medically indicated for maternal and fetal related conditions however elective induction has become more common since the ARRIVE trial Women with an unfavourable cervix according to Bishop-score 6 are prone to higher induction failure rates and are candidates for cervical ripening
The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle resulting in decreased muscle spasm and subsequent smooth-muscle relaxation The half-life of the drug is in the range of 05-2 hours and its action starts 10 minutes after administration Short-term use of papaverine during the first trimester has been reported as safe However outcome data are lacking of the use of mucosotropic-agents prior to PGE2 propess insertion We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval
The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle resulting in decreased muscle spasm and subsequent smooth-muscle relaxation The half-life of the drug is in the range of 05-2 hours and its action starts 10 minutes after administration Short-term use of papaverine during the first trimester has been reported as safe However outcome data are lacking of the use of mucosotropic-agents prior to PGE2 propess insertion We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None